FDA label ff163568-addd-41b7-b99d-22fa5dff2f7b

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID
a1741cbb-37a6-485d-9d62-5e096ddffa0e
SPL ID
ff163568-addd-41b7-b99d-22fa5dff2f7b
Version
2
Effective date
2021-09-03
Source export date
2026-09-28
Source partition
2
Source file
https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/f7d2b6e3f8600cd856280ab55a9c6fa54a642647191d164f9d1110e89f3f4097/drug-label-0002-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:16:09

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings For external use only Use only as directed Avoid contact with eyes and mucous membranes. Do not apply to open wounds or damaged skin. Store in cool dry place away from direct sunlight. If pregnant or breast-feeding Ask a health professional before use. Keep out of reach of children If accidentally ingested, get medical help or contact Poison Control Center immediately. Stop use and ask a doctor if Condition worsens Irritation or redness develops. Ask doctor before use If you have sensitive skin. Directions Shake well before each use. Keep cap on between uses. Adults and children 12 years of age or older: Apply generous amount to clean, unbroken skin. Allow lotion to rest on skin for approximately one minute Rub lotion into the target area. Reapply up to four times per day. Wash hands thoroughly after each application.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.